Status:
TERMINATED
High Density Lipoprotein Turnover
Lead Sponsor:
Sanofi
Conditions:
Obesity
Eligibility:
All Genders
35-65 years
Phase:
PHASE3
Brief Summary
The objective of the study is to evaluate the effect of Rimonabant 20mg in comparison to placebo, on HDL and VLDL lipoprotein kinetics, over a 12 months period. Primary objectives: * To assess effec...
Eligibility Criteria
Inclusion
- Abdominally obese patients with additional cardiometabolic risk factors
- Females must be post-menopausal
- BMI \> 27 kg/m² and \< 40 kg/m²
- Men or women with abdominal obesity according to NCEP/ATPIII criteria: Waist Circumference \> 88 cm in women; \> 102 cm in men
- With at least one lipid abnormality defined as:
- Fasting Triglycerides level \> 1.7 mmol/L (150 mg/dL) and \< 4.5 mmol/L (400 mg/dL)
- HDL \< 1.03 mmol/L (40 mg/dL) in men and \< 1.29 mmol/L (50 mg/dL) in women
Exclusion
- HDL ≤ 0.60 mmol/L (23 mg/dl)
- Plasma LDL-Cholesterol \> 155 mg/dl (4.00 mmol/L) or total cholesterol 250 mg/dl (\> 6.5mmol/L) or genetic hyperlipidaemia
- Fasting triglycerides \> 400 mg/dL (4.5 mmol/L)
- Known heterozygous or homozygous familial hypercholesterolaemia or know type III hyperlipoproteinaemia (familial dysbetalipoproteinaemia)
- ApoE2/E2 homozygosity, Apo E4/E4 homozygosity
- Type 2 diabetes treated with oral agents and/or insulin
- Diet treated type 2 diabetic patients with HbA1c ≥ 7%
- History of cardio vascular disease
- Systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 95 mmHg.
- Very low-calorie diet (1200 calories a day or less) or history of surgical procedures for weight loss (e.g., stomach stapling, bypass)
- Body weight fluctuation \> 5 Kg during the previous 3 months
- History of bulimia or anorexia nervosa by DSM-IV criteria
- Presence of any clinically significant endocrine disease according to the investigator, Cushing syndrome, obesity secondary to hypothalamic/pituitary disorder.
- Abnormal TSH and free T4 at baseline (Patients treated with thyroid replacement therapy must be on fixed and stable dose for at least 3 months prior to screening and must be in euthyroïd status.)
- Severe hepatic impairment known by the investigator or AST or ALT \> 3 times the ULN at screening.
- Known severe renal dysfunction (creatinine clearance \< 30 ml/min) or urine analysis (performed at screening by dipstick) showing 2+ or more protein
- Presence of any condition (medical, including clinically significant abnormal laboratory test, psychological, social or geographical) actual or anticipated that the investigator feels would compromise the patient safety or limit his/her successful participation to the study
- Patient treated for epilepsy
- Ongoing major depressive illness
- Uncontrolled psychiatric illness
- History of alcohol and/or drug abuse
- Smoker or smoking cessation within the past 3 months
- Marijuana or hashish users
- Previous participation in a Rimonabant study or to any other clinical trial within 4 weeks to study start
- Hypersensitivity/intolerance to the active substance or to any of the excipients such as lactose
- Blood donation within the past 3 months prior to the study or planned during the study or within the 3 months from the study completing
- Recent history of active peptic ulcer
- Willebrand disease or other hemorrhagic diatheses
- Administration of any of the following within 3 months prior to screening visit and susceptible to be prescribed during the study treatment period:
- Lipid-lowering drugs intake
- Anti obesity drugs
- Other drugs for weight reduction (phentermine, amphetamines)
- Herbal preparations for weight reduction
- Other drugs known to affect lipid metabolism: retinoids, antiretroviral, estrogens and hormone replacement therapy, cyclosporine, glitazones, benfluorex, fish oils, plant sterols.
- Thiazids (including fixed combination) at daily dose higher than 12.5 mg
- Unselective beta-blockers
- Prolonged use (more than one week) of systemic corticosteroids, neuroleptics
- Anticoagulants
- Ongoing antidepressive treatment
- The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
Key Trial Info
Start Date :
October 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2008
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT00408148
Start Date
October 1 2006
End Date
December 1 2008
Last Update
December 10 2010
Active Locations (4)
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1
Sanofi-Aventis Administrative Office
North Ryde, Australia
2
Sanofi-Aventis Administrative Office
Helsinki, Finland
3
Sanofi-Aventis Administrative Office
Paris, France
4
Sanofi-Aventis Administrative Office
Guildford, United Kingdom